Double-Blind Placebo-Controlled Study of Acamprosate in Autism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline to week 10 on the Social WIthdrawal subscale of ABC
研究概览
简要总结
Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.
详细描述
Each subject with ASD will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5-17 year-old outpatients
- •Diagnosis of ASD
- •General good health (determined by exam, history, and laboratory work up)
- •Use of up to two concomitant psychotropic drugs (stable dosing for >60 days) not impacting glutamate or gamma-aminobutyric acid A (GABA) neurotransmission is allowed
- •Stable seizure disorder (no seizures in 6 months; on same anti-convulsant dose for >60 days)
- •Clinical Global Impression Scale Severity score (CGI-S) of 4 (Moderately III)
- •Score of 13 on the Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW) at screen and baseline
排除标准
- •Potential subjects with a creatinine clearance < 50 mL/min or evidence of a previous trial of acamprosate will be excluded
研究组 & 干预措施
Placebo/sugar pill
Placebo will be dosed similar to acamprosate, in terms of dosage form, frequency and duration.
干预措施: Placebo (Drug)
Acamprosate
Acamprosate: The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 50kg and 1332 mg per day for those less weighing less than 50kg.
Other Name: Campral
干预措施: Acamprosate (Drug)
结局指标
主要结局
Change from baseline to week 10 on the Social WIthdrawal subscale of ABC
时间窗: Week 10
The subscales of the ABC including the Social Withdrawal subscale have proven to be reliable measure of symptoms and behaviors associated with ASD. Specifically, the ABC-SW has been validated as a measure of social impairment that differentiates the social behavior of persons with ASD from those developmental delay without a comorbid ASD diagnosis.
Change Clinical Global Impression- Improvement
时间窗: Week 10
The CGI-I is a 7-point scale designed to measure symptomatic change at a specific time as compared to baseline. The CGI-I will be focused on the target symptoms of social impairment.
次要结局
- Change in ABC subscales: Irritability, Stereotypy, Hyperactivity, and Inappropriate Speech from baseline to week 10(Week 10)